Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
73729–73752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2003
WU'S 3-WHEELED NEO SCOOTER, WT-T3B
K023168 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 123d
Cleared Jan 24, 2003
PICUS ULTRASOUND IMAGING SYSTEMS
K023512 · IYN
Pie Medical
Radiology · 95d
Cleared Jan 24, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023568 · LON
Becton, Dickinson & CO
Microbiology · 92d
Cleared Jan 24, 2003
SILVERLON CONTACT WOUND DRESSING
K023612 · FRO
Argentum International, LLC
General & Plastic Surgery · 88d
Cleared Jan 24, 2003
PICCOLO TRIGLYCERIDES TEST SYSTEM
K023639 · JGY
Abaxis, Inc.
Chemistry · 86d
Cleared Jan 24, 2003
PICCOLO HDL TEST SYSTEM
K023640 · LBS
Abaxis, Inc.
Chemistry · 86d
Cleared Jan 24, 2003
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
K023642 · CHH
Abaxis, Inc.
Chemistry · 86d
Cleared Jan 24, 2003
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
K023650 · MOS
Usa Instruments, Inc.
Radiology · 86d
Cleared Jan 24, 2003
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
K023826 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 67d
Cleared Jan 24, 2003
UCP DENTAL MATERIAL
K023831 · EJT
Precious Chemicals U.S.A., Inc.
Dental · 67d
Cleared Jan 24, 2003
POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES
K023866 · LYY
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 65d
Cleared Jan 24, 2003
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K023878 · NFA
Medtronic Vascular
Cardiovascular · 64d
Cleared Jan 24, 2003
QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
K023970 · IZI
Medis Medical Imaging Systems BV
Radiology · 56d
Cleared Jan 24, 2003
PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K023977 · LYY
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITRILE EXAMINATION GLOVES, POWDER FREE
K023978 · LZA
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITRILE EXAMINATION GLOVES, PRE-POWDERED
K023979 · LZA
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITREX NITINOL GUIDEWIRE
K024021 · DQX
Ev3 Corporation
Cardiovascular · 50d
Cleared Jan 24, 2003
SHARP VIEW IMAGE ENHANCEMENT SYSTEM
K024028 · LLZ
Context Vision AB
Radiology · 49d
Cleared Jan 24, 2003
IVUS PLUS
K024103 · LLZ
Indec Systems, Inc.
Radiology · 43d
Cleared Jan 24, 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · DQX
Guidant Corp.
Cardiovascular · 21d
Cleared Jan 24, 2003
BURBANK TENACULUM, MODEL 09-0011-01
K030078 · HDC
Vascular Control Systems, Inc.
Obstetrics & Gynecology · 15d
Cleared Jan 24, 2003
H2 HEATED HUMIDIFIER
K030090 · BTT
Respironics, Inc.
Anesthesiology · 14d
Cleared Jan 24, 2003
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
K030102 · JJT
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 24, 2003
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
K030179 · NKX
Surgical Instruments Service and...
Ophthalmic · 7d